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Herceptin go ahead for gastric cancer

Roche's Herceptin has been granted a licence for treatment of patients in the UK with HER2-positive metastic adenocarcinoma of the stomach

Roche has announced that Herceptin (trastuzumab) has been granted a licence for treatment in the UK of patients with HER2-positive metastic adenocarcinoma of the stomach or gastro-oesophageal junction with standard chemotherapy (Xeloda [capecitabine] or 5-fluorouracil [5-FU] and cisplatin) who have not received prior anti-cancer treatment for their metastatic disease.

The licence follows the Committee for Medicinal Products for Human Use's (CHMP) positive opinion in December 2009 based on results from the international phase III ToGA (Trastuzumab for GAstric Cancer) trial. The National Institute for Health and Clinical Excellence (NICE) will review trastuzumab for the treatment of HER2-positive metastatic gastric cancer in 2010. It is anticipated guidance will be given by the end of 2010.

Consultant oncologist at Mount Vernon Cancer Centre, London, Dr Mark Harrison, said: "Trastuzumab is the first ever biological drug that is effective against HER2-positive metastatic gastric cancer and represents a major clinical advance in the treatment of these patients. The ToGA trial results show unprecedented life-prolonging benefits, giving patients significant and valuable extra time and quality of life."

Harrison added: "Trastuzumab's efficacy in these patients with gastric cancer demonstrates the important principle that targeting HER2-positive tumours is not restricted to breast cancer. Patients diagnosed with metastatic gastric cancer should be tested to find out their HER2 status to check if they are eligible for trastuzumab as a treatment option, in combination with chemotherapy. For one in six patients their gastric cancer will be HER2-positive, so for the first time ever we may be able to improve their chances to live beyond a year."

Trastuzumab, combined with chemotherapy, extends the lives of patients whose tumours show higher levels of the protein HER2, increasing their median survival time to 16 months versus 11.8 months for patients receiving chemotherapy alone. This is a 35 per cent increase in overall survival (exploratory analysis). Chemotherapy as a treatment alone generally confers an average survival time of 10 to 11 months.

Andrew Wilson-Webb, chief executive of the Rarer Cancers Forum, comments: "There are around 8,000 new cases of gastric cancer diagnosed in the UK each year. It is a particularly distressing form of the disease with few treatment options so the approval of trastuzumab, combined with chemotherapy, represents a significant advance in how patients with this type of metastatic gastric cancer are treated. Most importantly, it brings hope to these patients and their families."

The absence of NICE guidance does not restrict the prescribing of trastuzumab for HER2 positive gastric cancer. Department of Health Good Practice Guidance states that it is not acceptable to cite lack of NICE guidance as a reason for not prescribing a specific treatment.

8th February 2010

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